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AIM ImmunoTech Inc. (AIM)

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0.8500+0.0320 (+3.91%)
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0.8189 -0.03 (-3.66%)
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  • T
    Tom
    That ovarian cancer study being pumped by polakowski did not measure efficacy, but measured some biological markers such as gene activation. There were four cohorts in the study. All received Ampligen, but only cohorts 2,3 and 4 also received interferon-alpha. Cohort 1 received Ampligen but no interferon-alpha. Interestingly, there was a difference between those who received the interferon with those who received only Ampligen.

    "Using type I interferon stimulated genes (ISGs) from a previously reported gene signature (31), we found that all the 26 ISGs included in our NanoString panel showed significant changes upon the addition of CKM but not after chemotherapy alone (Fig. 2D). Importantly, ISG upregulation is most prominent in patients from cohorts 2-4 (who received IFN-alpha) but not from cohort 1 (no IFN-alpha), suggesting a drug-specific effect. "

    Perhaps this is why the company is not trumpeting this study. And perhaps the researchers are considering going with another TLR3 agonist.

    All of this also echoes what the Johns Hopkins study showed:

    "A surprising finding was the absence of detectable alpha or gamma interferon after administration of a drug that is an interferon inducer in vitro (6)."
  • B
    BenKenobi
    Well, if I'm honest, I'd say that Luc and Tom have probably been right all along. Sure seems like Ampligen is SCAMpligen.
  • m
    matty
    Will the plebs grab that .24 support on their way out? Im waiting for $100 plus myself. Taken 6-years to get out of this massive max cloud, but i can’t wait to watch the shorts burn over $2.45.
  • T
    Tom
    Over the course of HEB/AIM's ride down from $8778 per share (adjusted for reverse-splits) to $0.82 per share, I have come to the conclusion that HEB/AIM is one case in which past performance is indicative of future results.

    This stock could easily be back below 0.10 a share by the summer, and we could be hearing warnings about yet another reverse-split near the end of the year.

    The only thing to stop this would be some new dread disease popping up in the headlines and yet another fresh crop of credulous investors popping up who are willing to swallow the company's bait yet again.
  • E
    Edgar
    I,m here😀
  • L
    Luc
    0.00162443 pré splits for a stock that can help pancreatic cancer patients ?

    keep on dreaming : a scam is a scam
  • L
    Luc
    The free fall of the value of this scam continues ( 0.78 AH ) and the depreciation will increase even further, once all the bag holders realise they have been misled .... just mho
  • T
    Tom
    Somtimes, HEB/AIM pumpers try to argue that the FDA found that Ampligen was safe. That is not actually true.

    At the ADCOM meeting they voted that if you were take the safety data "at face value" then Ampligen might appear safe, but that the safety data was too shoddy an unreliable to make such a determination. Also, in the Complete Response Letter from the FDA the FDA cited the lack of proof of safety as one of the reasons for rejected Ampligen.

    From the minutes of the ADCOM meeting:

    "4) VOTE: Has the safety of Ampligen been adequately assessed and characterized for the
    treatment of chronic fatigue syndrome (CFS)?

    Vote: Yes= 4 No = 9 Abstain = 0 No Voting = 1

    Committee Discussion: The majority of the committee did not agree that the safety of
    Ampligen has been adequately assessed and characterized for the treatment of CFS, based
    on the limited size of the database and the multiple discrepancies and gaps in the safety data
    of the Ampligen clinical program. Some members stated that they had no confidence in the
    veracity of the data and questioned whether the data were deceptive or just shoddy."

    5) VOTE: Is the safety profile of Ampligen adequate for approval for the treatment of CFS?

    Vote: Yes= 8 No = 5 Abstain = 0 No Voting = 1

    Committee Discussion: While the committee members expressed that the safety profile of
    Ampligen has not been adequately characterized for approval, many stated that if taken at
    face value, the profile would be “good enough” for approval"

    From an HEB/AIM 8-K:

    "Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), announced that it received a Complete Response Letter from the US Food and Drug Administration (“FDA”) declining to approve its new drug application (“NDA”) for Ampligen® for Chronic Fatigue Syndrome (“CFS”). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

    In its Complete Response Letter (“CRL”), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen® for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data."
  • T
    Tom
    From a prior 10-K:

    "In December 1993, the FDA designated Ampligen as an orphan drug for the clinical indications of invasive malignant melanoma and chronic fatigue syndrome. "

    The FDA would go on to reject Ampligen as a treatment for CFS on two separate occasions, (2009 and 2013), citing a lack of credible evidence for efficacy or safety.

    Some people have tried to argue that the granting of orphan drug status indicates that the FDA has made some favorable assessment of a drug, but you can see that this is untrue even just from Ampligen's own history.

    And on the FDA's website: "Orphan drug designation is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process as any other drug for approval or licensing. "
  • c
    cindy
    10 Reasons Why Biotech Could Be the Hottest Sector in 2022
  • B
    Beauford
    Phase 1 Ovarian Cancer Study results just published. need to buy the full report to get all detail but topline data from the summary its safe, progression free survival 8 months and overall survival 30 months. remember this is recurrent ovarian cancer and sick patients. so on the surface looks solid. hey Luc thought they would never publish data??
    https://clincancerres.aacrjournals.org/content/early/2022/01/18/1078-0432.CCR-21-3659
  • T
    Tom
    FORM 8-K
    CURRENT REPORT
    Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report
    November 29, 2021

    ...We recently received a response from the U.S. Food and Drug Administration (“FDA”) to the investigational New Drug (“IND”) application we submitted in September 2021 for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The FDA response put a Clinical Hold on the proposed study. The FDA also denied our request for Fast Track status at this time. The FDA response outlined guidance and recommendations on the basis for the hold and other issues in the proposed protocol, and requested a response to the FDA’s basis for the hold and a separate amendment to the IND addressing the other issues in the FDA response. The FDA is requesting certain modifications to the protocol that will improve the protocol design. We have reviewed the FDA comments and are working to incorporate the required changes into a revised protocol. We hope to submit our responses to the FDA within the next month. "

    I think that the odds that HEB/AIM responded to this in a timely manner are poor. And it would appear rather doubtful whether Tom Equels & Co have the wherewithal to go through the process of removing a clinical hold.
  • T
    Tom
    At the last ADCOM meeting at which Ampligen was reviewed, the reviewers had trouble deciding whether the data that HEB/AIM submitted was shoddy or deceptive. "Shoddy Or Deceptive" would be a good motto for this company that has spent decades skulking in the gray hazy area between shoddy and deceptive.

    If they want it to sound fancier, their motto would be "NEGLIGENS VER FALLAX"

    From the transcript of that ADCOM meeting:

    "DR. GUALTIERI: What I'm trying to understand is, is there anything here that is actually considered deceptive, or is it shoddy? And then how does that affect my understanding of the efficacy and safety? "
  • L
    Luc
    For those who doesn't understand the scam mechanism : there will never be any positive news around the "effect" of the snake oil called "ampligen" ...
  • L
    Luc
    Those who think the scam BOD will publish positive human (pancreatic) cancer trial results are misled ...

    that will never happen ... not in january , not in the first quarter .... NEVER !
  • E
    Edgar
    Man,man is ging down again, for 40 cents i am believer 😂😂
  • T
    Tom
    I am curious, does jonjonson's self-invented "intra-day OBV analysis" still tell him that it is time to buy more AIM?
  • M
    Mg
    Time for Tom’s interview about Ampligen effect in Omicron and its clinical trial in Japan.
  • L
    Luc
    Some will have a different opinion , but I think you need to trust the BOD before starting investing in a stock...

    ask yourself : do you trust the HEB/AIM scam BOD and their "plan" to generate stockholders value ?

    do your own dd !!
  • Đ
    Đại
    Hopeless